Month: March 2023

Release – Sierra Metals Announces Fourth Quarter & Year End 2022 Consolidated Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SMT

MARCH 28, 2023

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Conference Call and Webcast will be held on March 29, 2023 at 11:00am ET

TORONTO–(BUSINESS WIRE)– Sierra Metals Inc. (TSX: SMT) (“Sierra Metals” or the “Company”) announces fourth quarter and year-end 2022 consolidated financial results. All amounts are in US dollars, unless otherwise noted.

Fourth Quarter and Year-End 2022 Operating and Financial Highlights

  • Revenue from metals payable of $46.2 million in Q4 2022 and $192.1 million in 2022.
  • Adjusted EBITDA(1) of ($0.5) million in Q4 2022 and $13.0 million in 2022.
  • Net loss attributable to shareholders for Q4 2022 of $26.5 million, or $0.16 per share and $87.5 million, or $0.53 per share in 2022.
  • Net loss of $88.3 million, or $0.54 in 2022, which includes impairment charges of $25.0 million for the Bolivar mine and $25.0 million for the Cusi mine; and $5.3 million non-cash depletion.
  • Cash and cash equivalents as at December 31, 2022 was $5.1 million; negative working capital of $84.4 million.
  • The focus in 2023 is to improve safety practices, reduce costs, improve productivity through increased equipment availability.

On March 13, 2023, the Company improved short-term liquidity through refinancing $6,250,000 of debt repayments due March 2023, with negotiations ongoing to refinance a total of $18,750,000 of term loan amortization payments due in 2023.

Ernesto Balarezo Valdez, Sierra Metals’ Interim CEO comments, “Sierra Metals enters 2023 with positive momentum. Since the start of 2023, we have stabilized our operations and begun to implement a program to optimize our operating performance, all with safety as the top priority. The expected operational improvements, alongside the corporate initiatives to improve our balance sheet, which includes the recently announced debt refinancing initiatives, has set the stage for Sierra Metals to increase production, lower costs and improve our financial position.”

(1) This is a non-IFRS performance measure, see Non-IFRS Performance Measures section of the MD&A.

Strategic Update

As first announced on October 18, 2022, a special committee comprised of the Company’s independent directors (the “Special Committee”) is undertaking a strategic review process. The mandate of the Special Committee includes exploring, reviewing and considering options to optimize the operations of the Company and possible financing, restructuring and strategic options in the best interests of the Company. The Company has engaged CIBC Capital Markets as a financial advisor in this process.

The Special Committee continues to evaluate certain strategic alternatives. The Company will report to shareholders upon completion of the Special Committee’s review. Concurrently, over the course of the strategic review process the Special Committee and the management team have identified and have implemented a number of opportunities to improve the Company’s operational and financial position.

Progress made to-date includes the following:

  • Successfully implementing a transition of executive level management.
  • Organizational changes designed to create a shift in the corporate culture and instill a more “hands-on” approach to operations.
  • Placing a renewed emphasis on safety and employee engagement. The Company has hired a VP of Health and Safety, instituted new safety protocols across all of its operations, increased training and communication efforts, and invested in remote-controlled equipment which is designed to reduce risk of injury.
  • Streamlining operations to reduce costs, and refinancing debt obligations in order to preserve working capital as production levels improve.
  • Advancing discussions with secured lenders on refinancing of material short-term obligations, and steps to improve short-term liquidity through ancillary financing arrangements.
  • Initiatives to increase productivity at the mines, including increasing asset utilization, focused underground development of mine sequencing, and improvements to ventilation and pumping systems.
  • Prioritizing spending to focus resources on the Company’s core assets at Yauricocha and Bolivar.
  • Initiating activities designed to identify additional mineral resources at the Yauricocha and Bolivar mines to sustain long-term production increases.
  • Enhancements to internal financial forecasting, reporting and integration of information across functions to ensure timely decision making.

2023 Guidance

Production Guidance

The Bolivar mine exited fourth quarter 2022 with improved operations and expectations of continued improved performance throughout 2023. The Yauricocha mine is expected to gradually and safely ramp up production throughout 2023 at the current depth. Meanwhile, Yauricocha’s focus will remain on obtaining the necessary permits to access the deeper, high-grade ore bodies.

The table summarizing 2023 production guidance from the Yauricocha and the Bolivar mines is provided below. Management considers the Cusi mine as ‘non-core’ and it has been excluded from the guidance.

Total sustaining capital for 2023, excluding Cusi, is expected to be $32.0 million, mainly comprised of mine development ($3.0 million) and drainage ($2.3 million) in Yauricocha, and mine development ($11.3 million), infill drilling ($5.3 million) and equipment replacement ($3.9 million) at the Bolivar mine.

Growth capital for 2023, projected at $15.0 million, includes costs of tailings dam expansion ($5.6 million) and Yauricocha shaft ($3.2 million) in Peru. Growth capital at Bolivar includes costs of the tailings dam and the starter dam.

Management will continue to review performance throughout the year, while exploring value enhancing opportunities.

Conference Call & Webcast

The Company will host a conference call on Wednesday, March 29, 2023, at 11:00 AM EDT to discuss the results. Details of the conference call and webcast are as follows:

Date:March 29, 2023
Time:11:00 am ET
Webcast:https://events.q4inc.com/attendee/111210337
Telephone:Access code: 077974
Canada: 1 833 950 0062 (toll free)
USA: 1 844 200 6205 (toll free)
Other: 1 929 526 1599

The webcast, presentation slides and 2022 Financial Statements and Management Discussion and Analysis will be available at www.sierrametals.com, with an archive of the webcast available for 180 days.

Summary of Operating and Financial Results

The information provided below are excerpts from the Company’s Annual Financial Statements and Management’s Discussion and Analysis, which are available on the Company’s website (www.sierrametals.com) and on SEDAR (www.sedar.com) under the Company’s profile.

2022 Consolidated Financial Summary

  • Revenue from metals payable of $192.1 million in 2022, a decrease of 29% from 2021 annual revenue of $272.0 million. Lower revenue resulted from the decrease in throughput and grades at the Yauricocha and Bolivar mines;
  • Yauricocha’s cash cost per copper equivalent payable pound(1) was $2.23 (2021 – $1.46), and AISC per copper equivalent payable pound(1) of $3.69 (2021 – $2.77);
  • Bolivar’s cash cost per copper equivalent payable pound(1) was $2.99 (2021 – $2.18), and AISC per copper equivalent payable pound(1) was $5.07 (2021 – $4.22);
  • Cusi’s cash cost per silver equivalent payable ounce(1) was $16.77 (2021 – $16.71), and AISC per silver equivalent payable ounce(1) was $23.17 (2021 – $28.15);
  • Adjusted EBITDA(1) of $13.0 million for 2022, a decrease from the adjusted EBITDA(1) of $104.7 million for 2021;
  • Net loss attributable to shareholders for 2022 was $87.5 million or $0.53 per share (2021: net loss of $27.4 million, $0.17 per share). Net loss for the year ended 2022 includes an impairment charge of $25.0 million on the Bolivar mine and $25.0 million on the Cusi mine (2021: impairment of $35.0 million on the Cusi mine);
  • Adjusted net loss attributable to shareholders(1) of $23.1 million, or $0.14 per share, for 2022 compared to the adjusted net income(1) of $21.6 million, or $0.13 per share for 2021;
  • A large component of the net income (loss) for every period is the non-cash depletion charge in Peru, which was $5.3 million for 2022 (2021: $9.3 million). The non-cash depletion charge is based on the aggregate fair value of the Yauricocha mineral property at the date of acquisition of Sociedad Minera Corona S.A. de C.V. (“Corona”) of $371.0 million amortized over the life of the mine;
  • Cash flow generated from operations before movements in working capital of $5.2 million for 2022 was lower than the $91.1 million in 2021, mainly due to lower revenues and higher operating costs; and
  • Cash and cash equivalents of $5.1 million and working capital of $(84.4) million as at December 31, 2022 compared to $34.9 million and $17.3 million, respectively, at the end of 2021. Cash and cash equivalents decreased during 2022 as the $38.3 million used in investing activities exceeded the $1.1 million generated from financing activities and $7.3 million generated from operating activities.

(1) This is a non-IFRS performance measure, see Non-IFRS Performance Measures section of the MD&A.

Non-IFRS Performance Measures

The non-IFRS performance measures presented do not have any standardized meaning prescribed by IFRS and are therefore unlikely to be directly comparable to similar measures presented by other issuers.

Non-IFRS reconciliation of adjusted EBITDA

EBITDA is a non-IFRS measure that represents an indication of the Company’s continuing capacity to generate earnings from operations before taking into account management’s financing decisions and costs of consuming capital assets, which vary according to their vintage, technological currency, and management’s estimate of their useful life. EBITDA comprises revenue less operating expenses before interest expense (income), property, plant and equipment amortization and depletion, and income taxes. Adjusted EBITDA has been included in this document. Under IFRS, entities must reflect in compensation expense the cost of share-based payments. In the Company’s circumstances, share-based payments involve a significant accrual of amounts that will not be settled in cash but are settled by the issuance of shares in exchange for cash. As such, the Company has made an entity specific adjustment to EBITDA for these expenses. The Company has also made an entity-specific adjustment to the foreign currency exchange (gain)/loss. The Company considers cash flow before movements in working capital to be the IFRS performance measure that is most closely comparable to adjusted EBITDA.

The following table provides a reconciliation of adjusted EBITDA to the consolidated financial statements for the three months and years ended December 31, 2022 and 2021:

Non-IFRS Reconciliation of Adjusted Net Income (Loss)

Adjusted net income (loss) attributable to shareholders represents net income (loss) attributable to shareholders excluding certain impacts, net of taxes, such as non-cash depletion charge due to the acquisition of Corona, impairment charges and reversal of impairment charges, write-down of assets, and certain non-cash and non-recurring items including but not limited to share-based compensation and foreign exchange (gain) loss.The Company believes that, in addition to conventional measures prepared in accordance with IFRS, certain investors may want to use this information to evaluate the Company’s performance and ability to generate cash flows. Accordingly, it is intended to provide additional information and should not be considered in isolation or as a substitute for measures of performance in accordance with IFRS.

The following table provides a reconciliation of adjusted net income (loss) to the consolidated financial statements for the three months and years ended December 31, 2022 and 2021:

Cash Cost per Silver Equivalent Payable Ounce and Copper Equivalent Payable Pound

The Company uses the non-IFRS measure of cash cost per silver equivalent ounce and copper equivalent payable pound to manage and evaluate operating performance. The Company believes that, in addition to conventional measures prepared in accordance with IFRS, certain investors use this information to evaluate the Company’s performance and ability to generate cash flows. Accordingly, it is intended to provide additional information and should not be considered in isolation or as a substitute for measures of performance prepared in accordance with IFRS. The Company considers cost of sales per silver equivalent payable ounce and copper equivalent payable pound to be the most comparable IFRS measure to cash cost per silver equivalent payable ounce, copper equivalent payable pound, and zinc equivalent payable pound, and has included calculations of this metric in the reconciliations within the applicable tables to follow.

All-in Sustaining Cost per Silver Equivalent Payable Ounce and Copper Equivalent Payable Pound

All‐In Sustaining Cost (“AISC”) is a non‐IFRS measure and was calculated based on guidance provided by the World Gold Council (“WGC”) in June 2013. WGC is not a regulatory industry organization and does not have the authority to develop accounting standards for disclosure requirements. Other mining companies may calculate AISC differently as a result of differences in underlying accounting principles and policies applied, as well as differences in definitions of sustaining versus development capital expenditures.

AISC is a more comprehensive measure than cash cost per ounce/pound for the Company’s consolidated operating performance by providing greater visibility, comparability and representation of the total costs associated with producing silver and copper from its current operations.

The Company defines sustaining capital expenditures as, “costs incurred to sustain and maintain existing assets at current productive capacity and constant planned levels of productive output without resulting in an increase in the life of assets, future earnings, or improvements in recovery or grade. Sustaining capital includes costs required to improve/enhance assets to minimum standards for reliability, environmental or safety requirements. Sustaining capital expenditures excludes all expenditures at the Company’s new projects and certain expenditures at current operations which are deemed expansionary in nature.”

Consolidated AISC includes total production cash costs incurred at the Company’s mining operations, including treatment and refining charges and selling costs, which forms the basis of the Company’s total cash costs. Additionally, the Company includes sustaining capital expenditures and corporate general and administrative expenses. AISC by mine does not include certain corporate and non‐cash items such as general and administrative expense and share-based payments. The Company believes that this measure represents the total sustainable costs of producing silver and copper from current operations and provides the Company and other stakeholders of the Company with additional information of the Company’s operational performance and ability to generate cash flows. As the measure seeks to reflect the full cost of silver and copper production from current operations, new project capital and expansionary capital at current operations are not included. Certain other cash expenditures, including tax payments, dividends and financing costs are also not included.

The following table provides a reconciliation of cash costs to cost of sales, as reported in the Company’s consolidated statement of income for the three months and years ended December 31, 2022 and 2021:

Additional Non-IFRS Measures

The Company uses other financial measures, the presentation of which is not meant to be a substitute for other subtotals or totals presented in accordance with IFRS, but rather should be evaluated in conjunction with such IFRS measures. The following other financial measures are used:

  • Operating cash flows before movements in working capital – excludes the movement from period-to-period in working capital items including trade and other receivables, prepaid expenses, deposits, inventories, trade and other payables and the effects of foreign exchange rates on these items.

The terms described above do not have a standardized meaning prescribed by IFRS, and therefore the Company’s definitions are unlikely to be comparable to similar measures presented by other companies. The Company’s management believes that their presentation provides useful information to investors because cash flows generated from operations before changes in working capital excludes the movement in working capital items. This, in management’s view, provides useful information of the Company’s cash flows from operations and are considered to be meaningful in evaluating the Company’s past financial performance or its future prospects. The most comparable IFRS measure is cash flows from operating activities.

About Sierra Metals

Sierra Metals is a diversified Canadian mining company with green metal exposure including copper, zinc and lead production with precious metals byproduct credits, focused on the production and development of its Yauricocha Mine in Peru and its Bolivar Mine in Mexico. The Company is focused on the safety and productivity of its producing mines. The Company also has large land packages with several prospective regional targets providing longer-term exploration upside and mineral resource growth potential.

For further information regarding Sierra Metals, please visit www.sierrametals.com.

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Forward-Looking Statements

This press release contains forward-looking information within the meaning of Canadian securities legislation. Forward-looking information relates to future events or the anticipated performance of Sierra and reflect management’s expectations or beliefs regarding such future events and anticipated performance based on an assumed set of economic conditions and courses of action, including the accuracy of the Company’s current mineral resource estimates; that the Company’s activities will be conducted in accordance with the Company’s public statements and stated goals; that there will be no material adverse change affecting the Company, its properties or its production estimates (which assume accuracy of projected ore grade, mining rates, recovery timing, and recovery rate estimates and may be impacted by unscheduled maintenance, labour and contractor availability and other operating or geo-political uncertainties on the Company’s production, workforce, business, operations and financial condition); the expected trends in mineral prices, inflation and currency exchange rates; that all required approvals will be obtained for the Company’s business and operations on acceptable terms; that there will be no significant disruptions affecting the Company’s operations. In certain cases, statements that contain forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “believes” or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, or “will be taken”, “occur” or “be achieved” or the negative of these words or comparable terminology. Forward-looking statements include those relating to the Company’s guidance on the timing and amount of future production and its expectations regarding the results of operations; expected costs; permitting requirements and timelines; anticipated market prices of metals; the Company’s ability to comply with contractual and permitting or other regulatory requirements; formalizing the refinancing contract and the timeline related thereto and the timing of senior management’s conference call to discuss the Company’s financial and operating results for the year ended December 31, 2022. By its very nature forward-looking information involves known and unknown risks, uncertainties and other factors that may cause actual performance of Sierra to be materially different from any anticipated performance expressed or implied by such forward-looking information.

Forward-looking information is subject to a variety of risks and uncertainties, which could cause actual events or results to differ from those reflected in the forward-looking information, including, without limitation, the risks of not meeting the expectations contemplated herein and the risks described under the heading “Risk Factors” in the Company’s annual information form dated March 28, 2023 for its fiscal year ended December 31, 2022 and other risks identified in the Company’s filings with Canadian securities regulators, which filings are available at www.sedar.com.

The risk factors referred to above are not an exhaustive list of the factors that may affect any of the Company’s forward-looking information. Forward-looking information includes statements about the future and is inherently uncertain, and the Company’s actual achievements or other future events or conditions may differ materially from those reflected in the forward-looking information due to a variety of risks, uncertainties and other factors. The Company’s statements containing forward-looking information are based on the beliefs, expectations, and opinions of management on the date the statements are made, and the Company does not assume any obligation to update such forward-looking information if circumstances or management’s beliefs, expectations or opinions should change, other than as required by applicable law. For the reasons set forth above, one should not place undue reliance on forward-looking information.

Investor Relations
Sierra Metals Inc.
Tel: +1 (416) 366-7777
Email: info@christiana-papadopoulossierrametals-com

Source: Sierra Metals Inc.

Noble Capital Markets Annual Investor Conference – NobleCon – to be held at Florida Atlantic University December 3-5

Posted on by cpatches

———-

Noble Capital Markets Annual Investor Conference – NobleCon – to be held at Florida Atlantic University December 3-5

Boca Raton, FL, March 1, 2023 (GLOBE NEWSWIRE) — In a joint statement, Noble Capital Markets, Inc. (“Noble”) and Florida Atlantic University announced today that NobleCon19 – Noble’s 19th Annual Small Cap Investor Conference – will be held at the University’s College of Business Executive Education facility, Dec. 3-5, 2023, in Boca Raton, Florida. The 52,000 square foot, state-of-the-art facility was opened August 2020. 

Noble has worked with the University for over a decade and was instrumental in the development of their Financial Analyst Program, and Noble’s Intern Program has generated great assets with graduates from the University. “We are extremely proud of our long-standing relationship with Florida Atlantic University,” said Nico Pronk, Noble’s President & CEO. “This new collaboration certainly elevates it to a whole new level.”

Vegar Wiik, Executive Director of the College of Business, Executive Education agrees, stating “Our vision for the College and this magnificent structure is to effectively integrate our curriculum with established businesses. Daniel Gropper, dean of FAU’s College of Business, said the financial industry is an important, integral part of the economy. “I can’t think of a better way to expose our students to the importance of emerging growth companies than to have 100 plus executive teams in the halls of our campus,” he said.

The entire College of Business Executive Education facility will transform into NobleCon19. Each presentation room will accommodate investors, in tiered seating with personal monitors. High-definition cameras, full-room microphones (to capture audience questions), three large screens, and full webcasting capabilities will offer the most technologically advanced conference environment on the circuit. Attendees will also experience similarly equipped rooms for panel presentations, private breakouts, and meetings, and in large gathering spaces, both indoors and out, as well as 800 free covered parking spaces. Florida Atlantic University is centrally located in Boca Raton, off I-95, only minutes from the Boca Raton Airport, and less than half an hour from Fort Lauderdale International Airport. Privaira, located at Boca Raton Airport is the official private air charter company for NobleCon19. A wide range of hotel accommodations are available within a five-mile radius, from economy to the ultra-luxurious “The Boca Raton.” Noble will be working with several properties to offer NobleCon19 attendees discounted rates.

The format of NobleCon will include company presentations followed by fire-side chats with Noble analysts, and select one-on-one meetings for qualified investors only, as well as several industry panel presentations. On the networking side, Noble is planning for informative keynote speakers and live entertainment, in an effort expand the business day in a more casual, conversational environment. All company presentations and panel discussions will be digitally streamed and made available exclusively on www.channelchek.com – Noble’s proprietary investment community portal.

Who should attend? Public companies from any business sector with market capitalizations of below $3-4 billion. Private companies planning a capital raise, considering becoming public, or an M&A event. NobleCon19 will suit every level of investor; high net worth individuals, family offices, self-directed investors, private equity, RIAs, financial advisors, equity analysts, and institutional investors. www.NobleCon19.com

About Florida Atlantic University

Florida Atlantic University, established in 1961, officially opened its doors in 1964 as the fifth public university in Florida. Today, the University serves more than 30,000 undergraduate and graduate students across six campuses located along the southeast Florida coast. In recent years, the University has doubled its research expenditures and outpaced its peers in student achievement rates. Through the coexistence of access and excellence, FAU embodies an innovative model where traditional achievement gaps vanish. FAU is designated a Hispanic-serving institution, ranked as a top public university by U.S. News & World Report and a High Research Activity institution by the Carnegie Foundation for the Advancement of Teaching. For more information, visit www.fau.edu.

About Noble Capital Markets

Noble Capital Markets, Inc. was incorporated in 1984 as a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving underfollowed emerging growth companies through investment banking, wealth management, trading & execution, and equity research activities. Over the past 39 years, Noble has raised billions of dollars for companies and published more than 45,000 equity research reports. www.noblecapitalmarkets.com  contact@noblecapitalmarkets.com

PDS Biotechnology Corp. (PDSB) – 4Q22 Results Reported With Clinical Plan Updates For 2023

Posted on by cpereira@noblefcm.com


Wednesday, March 29, 2023

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

FY2022 Reported With Clinical Progress Updates. PDS Biotech reported a 4Q22 loss of $19.1 million or $(0.61) per share and a FY2022 loss of $40.9 million or $(1.43) per share. The loss included $10 million in licensing fees for PDS0301, paid with $5 million in cash and $5 million in stock.  Management updated its plans for Phase 3 trials for PDS0101 and PDS0301 during 2023. Cash on hand on December 31, 2022 was $73.8 million, which is expected to fund operations through 3Q24.

PDS Expects To Begin VERSATILE-003 In 4Q23. The Phase 2 VERSATILE-002 trial has reported strong results testing PDS0101 with Keytruda (pembrolizumab, a checkpoint inhibitor) for recurrent or metastatic head and neck cancer. Based on this data, PDS has received FDA guidance for the Phase 3 VERSATILE-003 trial. The trial protocols are being finalized with an IND submission expected in 2H23 and start of enrollment in 4Q23.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Alliance Resource Partners (ARLP) – Lowering Near-Term Estimates; Cash Flow Story Remains Favorable

Posted on by cpereira@noblefcm.com


Wednesday, March 29, 2023

ARLP is a diversified natural resource company that generates operating and royalty income from coal produced by its mining complexes and royalty income from mineral interests it owns in strategic oil & gas producing regions in the United States, primarily the Permian, Anadarko and Williston basins. ARLP currently produces coal from seven mining complexes its subsidiaries operate in Illinois, Indiana, Kentucky, Maryland and West Virginia. ARLP also operates a coal loading terminal on the Ohio River at Mount Vernon, Indiana. ARLP markets its coal production to major domestic and international utilities and industrial users and is currently the second largest coal producer in the eastern United States. In addition, ARLP is positioning itself as an energy provider for the future by leveraging its core technology and operating competencies to make strategic investments in the fast growing energy and infrastructure transition.

Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Lowering estimates. We have lowered our 2023 EBITDA and earnings per share estimates to $1.09 billion and $5.50 from $1.14 billion and $5.90, respectively. While we lowered our first half revenue expectations, our full year revenue estimate was increased based on greater contributions from the coal segment and expectations for an improved commodity price environment in the second half of the year. Notably, we refined and increased our operating cost estimates to reflect higher labor costs, sales-related expenses, and operational costs related to longwall moves within the mining segment.

First half challenged by declining commodity prices. Prices for crude oil and natural gas have declined throughout the year. While coal prices have softened in recent weeks, 34.7 million tons of the partnership’s 2023 planned coal sales, or 94% at the mid-point of guidance, were committed and priced as of the date of ARLP’s fourth quarter conference call. Year-to-date through March 28, crude oil and natural gas futures prices averaged $76.33 per barrel and $2.84 per thousand cubic feet (Mcf) compared to $80.47 per barrel and $4.48 per Mcf at the end of 2022 and $73.38 per barrel and $2.16 per Mcf as of March 28. As a result, we lowered our expectations for the oil & gas royalty segment.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Silicon Valley Technology Added to SVB’s Quick Demise

Posted on by phoffman@channelchek.com

SVB’s Newfangled Failure Fits a Century-Old Pattern of Bank Runs, With a Social Media Twist

The history of bank failures all have a familiar pattern. Based on past history, problems may still bubble up over the coming months. The internet and the ability for online withdrawals could elevate risks to banks. Rodney Ramcharan a Professor of Finance and Business Economics, University of Southern California, points out the similarities, the new challenges and provides his thoughts in his article that has been reprinted with permission from The Conversation.

The failure of Silicon Valley Bank on March 10, 2023, came as a shock to most Americans. Even people like myself, a scholar of the U.S. banking system who has worked at the Federal Reserve, didn’t expect SVB’s collapse.

Usually banks, like all companies, fail after a prolonged period of lackluster performance. But SVB, the nation’s 16th-largest bank, had been stable and highly profitable just a few months before, having earned about US$1.5 billion in profits in the last quarter of 2022.

However, financial history is filled with examples of seemingly stable and profitable banks that unexpectedly failed.

The demise of Lehman Brothers and Bear Stearns, two prominent investment banks, and Countrywide Financial Corp., a subprime mortgage lender, during the 2008-2009 financial crisis; the Savings and Loan banking crisis in the 1980s; and the complete collapse of the U.S. banking system during the Great Depression didn’t unfold in exactly the same way. But they had something in common: An unexpected change in economic conditions created an initial bank failure or two, followed by general panic and then large-scale economic distress.

The main difference this time, in my view, is that modern innovations may have hastened SVB’s demise.

Great Depression

The Great Depression, which lasted from 1929 to 1941, epitomized the public harm that bank runs and financial panic can cause.

Following a rapid expansion of the “Roaring Twenties,” the U.S. economy began to slow in early 1929. The stock market crashed on Oct. 24, 1929 – a date known as “Black Tuesday.”

The massive losses investors suffered weakened the economy and led to distress at some banks. Fearing that they would lose all their money, customers began to withdraw their funds from the weaker banks. Those banks, in turn, began to rapidly sell their loans and other assets to pay their depositors. These rapid sales pushed prices down further.

As this financial crisis spread, depositors with accounts at nearby banks also began queuing up to withdraw all their money, in a quintessential bank run, culminating in the failure of thousands of banks by early 1933. Soon after President Franklin D. Roosevelt’s first inauguration, the federal government resorted to shutting all banks in the country for a whole week.

These failures meant that banks could no longer lend money, which led to more and more problems. The unemployment rate spiked to around 25%, and the economy shrank until the outbreak of World War II.

Determined to avoid a repeat of this debacle, the government tightened banking regulations with the Glass-Steagall Act of 1933. It prohibited commercial banks, which serve consumers and small and medium-size businesses, from engaging in investment banking and created the Federal Deposit Insurance Corporation, which insured deposits up to a certain threshold. That limit has risen sharply over the past 90 years, from $2,500 in 1933 to $250,000 in 2010 – the same limit in place today.

S&L Crisis

The nation’s new and improved banking regulations ushered in a period of relative stability in the banking system that lasted about 50 years.

But in the 1980s, hundreds of the small banks known as savings and loan associations failed. Savings and loans, also called “thrifts,” were generally small local banks that mainly made mortgage loans to households and collected deposits from their local communities.

Beginning in 1979, the Federal Reserve began to hike interest rates very aggressively to fight the high inflation rates that had become entrenched.

By the early 1980s, Congress began allowing banks to pay market interest rates on depositers’ accounts. As a result, the interest rate S&Ls had to pay their customers was much higher than the interest income they were earning on the loans they had made in prior years. That imbalance caused many of them to lose money.

Even though about 1 in 3 S&Ls failed from around 1986 through 1992 – somewhere around 750 banks – most depositors at small S&Ls were protected by the FDIC’s then-$100,000 insurance limit. Ultimately, resolving that crisis cost taxpayers the equivalent of about $250 billion in today’s dollars.

Because the savings and loans industry was not directly connected to the big banks of that era, their collapse did not cause runs at the bigger institutions. Nevertheless, the S&L collapse and the government’s regulatory response did reduce the supply of credit to the economy.

As a result, the U.S. economy underwent a mild recession in the latter half of 1990 and first quarter of 1991. But the banking system escaped further distress for nearly two decades.

Great Recession

Against this backdrop of relative stability, Congress repealed most of Glass-Steagall in 1999 – eliminating Depression-era regulations that restricted the scope of businesses that banks could engage in.

Those changes contributed to what happened when, at the start of a recession that began in December 2007, the entire financial sector suffered a panic.

At that time, large banks, freed from the Depression-era restrictions on securities trading, as well as investment banks, hedge funds and other institutions outside the traditional banking system, had heavily invested in mortgage-backed securities, a kind of bond backed by pooled mortgage payments from lots of homeowners. These bonds were highly profitable amid the housing boom of that era, and they helped many financial institutions reap record profits.

But the Federal Reserve had been increasing interest rates since 2004 to slow the economy. By 2007, many households with adjustable-rate mortgages could no longer afford to make their larger-than-expected home loan payments. That led investors to fear a rash of mortgage defaults, and the values of securities backed by mortgages plunged.

It wasn’t possible to know which investment banks owned a lot of these vulnerable securities. Rather than wait to find out and risk not getting paid, most of the depositors rushed to get their money out by late 2007. This stampede led to cascading failures in 2008 and 2009, and the federal government responded with a series of big bailouts.

The government even bailed out General Motors and Chrysler, two of the country’s three largest automakers, in December 2008 to keep the industry from going bankrupt. That happened because the major car companies relied on the financial system to provide potential car buyers with credit to purchase or lease new cars. But when the financial system collapsed, buyers could no longer obtain credit to finance or lease new vehicles.

The Great Recession lasted until June 2009. Stock prices plummeted by more than 50%, and unemployment peaked at around 10% – the highest rate since the early 1980s.

As with the Great Depression, the government responded to this financial crisis with significant new regulations, including a new law known as the Dodd-Frank Act of 2010. It imposed stringent new requirements on banks with assets above $50 billion.

Close-Knit Customers

Congress rolled back some of Dodd-Frank’s most significant changes only eight years after lawmakers approved the measure.

Notably, the most stringent requirements were now reserved for banks with more than $250 billion in assets, up from $50 billion. That change, which Congress passed in 2018, paved the way for regional banks like SVB to rapidly expand with much less regulatory oversight.

But still, how could SVB collapse so suddenly and without any warning?

Banks take deposits to make loans. But a loan is a long-term contract. Mortgages, for example, can last for 30 years. And deposits can be withdrawn at any time. To reduce their risks, banks can invest in bonds and other securities that they can quickly sell in case they need funds for their customers.

In the case of SVB, the bank invested heavily in U.S. Treasury bonds. Those bonds do not have any default risk, as they are debt issued by the federal government. But their value declines when interest rates rise, as newer bonds pay higher rates compared with the older bonds.

SVB bought a lot of Treasury bonds it had on hand when interest rates were close to zero, but the Fed has been steadily raising interest rates since March 2022, and the yields available for new Treasurys sharply increased over the next 12 months. Some depositors became concerned that SVB might not be able to sell these bonds at a high enough price to repay all its customers.

Unfortunately for SVB, these depositors were very close-knit, with most in the tech sector or startups. They turned to social media, group text messages and other modern forms of rapid communication to share their fears – which quickly went viral.

Many large depositors all rushed at the same time to get their funds out. Unlike what happened nearly a century earlier during the Great Depression, they generally tried to withdraw their money online – without forming chaotic lines at bank branches.

Will More Shoes Drop?

The government allowed SVB, which is being sold to First Citizens Bank, and Signature Bank, a smaller financial institution, to fail. But it agreed to repay all depositors – including those with deposits above the $250,000 limit.

While the authorities have not explicitly guaranteed all deposits in the banking system, I see the bailout of all SVB depositors as a clear signal that the government is prepared to take extraordinary steps to protect deposits in the banking system and prevent an overall panic.

I believe that it is too soon to say whether these measures will work, especially as the Fed is still fighting inflation and raising interest rates. But at this point, major U.S. banks appear safe, though there are growing risks among the smaller regional banks.

Are Bank Regulators Illegally Punishing Crypto Users?

Posted on by phoffman@channelchek.com
Source: Coindesk (Flickr)

Washington DC Law Firm that Won Operation Choke Hold Suit, Gives Congress Advice

Are private digital assets, under unlawful attack by regulators? Sounds conspiratorial, but a D.C. law firm that successfully sued the FDIC, Federal Reserve, and Office of the Controller of the Currency (OCC), says they are doing just that. The firm Cooper & Kirk, won a large lawsuit dubbed against the agencies for their part in, “Operation Choke Point.”  That was a decade ago, the law firm now claims they have uncovered a coordinated campaign by bank regulators to drive crypto out of the U.S. financial system.

The new “Operation Choke Point 2.0,” according to the firms website, “have published informal guidance documents that single out cryptocurrency and cryptocurrency customers as a risk to the banking system.” According to an informational paper published by the D.C. firm, “businesses in the cryptocurrency marketplace are losing their bank accounts, or their access to the ACH network, suddenly, and with no explanation from their bankers, the paper continued, “the owners and employees of cryptocurrency firms are even having their personal accounts closed without explanation.”

As an example of could be viewed as overstepping their charters, the firm pointed out that, “over the past two weeks, federal regulators have shut down a solvent bank that was known to be serving the crypto industry and, although it is required to resolve banks through the “least cost resolution” to the Deposit Insurance Fund, the FDIC chose to shutter rather than sell the part of the bank that serves digital asset customers, costing the Fund billions of dollars.” The overall theme of the 37 page paper is that the targeting of certain businesses is going on to force them out of existence.

Source: White Paper on Operation Choke Point 2.0, Cooper & Kirk LLC

What are Regulators Accused Of

Specifically the regulators are being accused of:

  • Depriving businesses of their constitutional right to due process. This is a fifth amendment right that says that an entity tagging another with a derogatory label that causes injury (like lose bank accounts) The firm accuses that this is what the regulators have done by “labeling crypto a threat to the financial system.”
  • Violating both the non-delegation and anticommandeering doctrine by, “depriving Americans of Key Structural constitutional protections against the arbitrary exercise of government power.”
  • Refusing to perform their non-discretionary duties “when doing so will benefit the cryptocurrency industry.”
  • Evading rules that require periods of notice and comment of the rulemaking requirements of the administrative procedure act. It claims circumventing this is, “undemocratic.”
  • Acting in an arbitrary and capricious fashion by avoiding explaining underlying rules for their decisions. “It is difficult to imagine a more arbitrary and capricious agency action that simultaneously placing a solvent bank into receivership solely because it provided financial services to the cypto industry, while permitting insolvent institutions not tied to the crypto industry to continue operations.”

What is the Law Firms Stated Intent

Cooper and Kirk urge the U.S. Congress to perform its role and hold the agencies accountable. The firm urges the Congress to ask for all communications records related to these matters from the regulators.

The firm also would like for them to explain the basis for their conclusion that safety and soundness of the banking system requires the banking system be insulated from crypto. They would also like for it to be made clear to the agencies that the comment period of the Administrative procedure act is mandatory. It wanst an investigation into why Signature Bank was closed.

The last stated hope is fro Congress to investigate whether bank regulators are working to squelch innovation from the private sector in order to clear out competition for the benefit of existing regulated banks and a new federal crypto asset.

Take Away

Just like the first Operation Choke Point was targeting specific players, the new version does the same. The law firms stops short of any threats in their open paper, but it makes clear that the firm has solid experience achieving compliance if these maters.

https://www.cooperkirk.com/wp-content/uploads/2023/03/Operation-Choke-Point-2.0.pdf

Baudax Bio (BXRX) – Positive Results Announced From 2nd BX1000 Interim Analysis

Posted on by cpereira@noblefcm.com


Tuesday, March 28, 2023

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

All patients met Good or Excellent intubating conditions. In the 2nd interim pre-planned analyis released Monday, March 27th, 41 patients from 4 cohorts (at least 10 from each) met Good or Excellent intubating conditions, with 40 patients intubated at 60 seconds and 1 patient at 90 seconds. Treatments were generally well tolerated, and while there were no serious events, one patient experienced a treatment-emergent adverse event that could possibly be related to treatment. Based on the analysis, none of the four cohorts (3 different dose groups of BX1000, and a standard dose group of rocuronium) are expected to be dropped nor is the full 80-patient trial enrollment number expected to be adjusted.

Results similar to the 1st interim analysis. In late January, Baudax Bio released the 1st interim analysis that showed the 20 patients (5 patients from each of the four cohorts) met the criteria for Good or Excellent intubating conditions with no adverse events. As a reminder,  the primary endpoints assess the time frame needed to reach intubation conditions (time frame is within 2 minutes of administration) and also assess, using a standardized scale (Poor, Good, Excellent), the proportion of patients meeting Good or Excellent conditions. Secondary endpoints assess the safety and tolerability profile of BX1000.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Five Reasons to Get Excited About Mining Stocks

Posted on by phoffman@channelchek.com
Image Credit: Liontown Resources

M&A Trends Could Drive Mining Stocks Much Higher?

The building wave of M&A deals in at least two of the mining sectors, is difficult to ignore. This week, lithium miner Albemarle (ALB) disclosed it had submitted a proposal to acquire Liontown Resources (LTR.Australia). Last month Newmont Mining’s proposed acquisition of Newcrest Mining, highlighted the rising interest in M&A in the gold sector. To date, both proposals have been shunned, but as companies look to increase production, inflation increases producers capital outlays, plus long permitting processes, a case could be made that growth by acquisition, friendly or not, is becoming more appealing in the sector.

Typically growing demand to buy smaller companies in a sector puts upward pressure on valuations.

The gold and lithium sectors have mostly lead over the past six months in terms of deal-making. For gold, the largest driver is these miners remain undervalued by historical levels. The trend for lithium producers in the years ahead, as battery production ramps up to meet surging demand for electric storage and green technology, is expected to continue to accelerate.

The Price of lithium, key to batteries found in most EVs, over the years has risen. This created a situation where car manufacturers themselves have realized that the best way to ensure a key ingredient to their product is to own all or part of a large enough producer. Lithium producers are looking for ways to increase yield and own more production facilities. These factors could unfold into a situation where the stock prices of companies producing either of these two metals, and even other mined minerals with growing demand, could outperform other sectors.

Five Reasons to Explore Small Mining Companies

While the real heat is on producers of minerals used to make batteries and gold miners, the below supply/demand concepts may apply to an increased need for other miners to involve themselves in M&A as well.

  1. New List of Acquirers – The big car companies, energy companies,  and other additional industrial consumers are in need of reliable supply. 
  2. Cheaper to Buy than Find – M&A is a solution to the increased costs of growing organically. It also helps circumvent what could be permitting delays and supply chain problems that prevent headway.
  3. Scale – Gold companies normally try to extract synergies when seeking to size up, while lithium producers seek pure scale.
  4. Big Picture Economics – The economic environment favors miners if inflation remains elevated; the companies’ production is more likely to sell for more. The cost of money, on an opportunity cost basis, especially net of inflation (real interest) favors mining.
  5. Finding Value – Informed stock selection is key to discover and invest in companies best positioned to benefit from swelling M&A in the sector.

The fifth on this list is less of a reason to explore mining companies and more a common sense reminder. Last week the Channelchek Take Away Series brought to viewers a live in-depth presentation of 12 mining companies that were just coming off the huge PDAC mining conference in Canada. These presentations are being replayed and may be just the place to begin to hear from company executives, and a highly respected senior natural resources analyst. Audience questions and answers follow.

The information on these on-demand replay videos is current, and as you’ll see by clicking here, the list of video presentations includes a diversified mix of producers and explorers.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.barrons.com/articles/how-to-handle-an-uncertain-market-buy-weakness-sell-strength-f145c306

Release – Ocugen Announces FDA Approval for Enrollment Of Pediatric Patients In Ongoing Ocu400 Phase 1/2 Clinical Trial For The Treatment Of Retinitis Pigmentosa (Rp) And Leber Congenital Amaurosis (LCA)

Posted on by aweinsoff@channelchek.com

Research News and Markert Data on OCGN

  • U.S. Food & Drug Administration (FDA) approves enrolling pediatric patients in the ongoing OCU400 Phase 1/2 trial who have: 1) RP associated with NR2E3 and RHO mutations and 2) LCA associated with CEP290 gene mutations

  • Ocugen has completed enrollment of adult RP patients with NR2E3 and RHO mutations in the Phase 1/2 trial and expanded enrollment in LCA patients with CEP290 mutations

MALVERN, Pa., March 27, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the FDA approved enrolling pediatric patients in the ongoing OCU400 Phase 1/2 trial.

“This approval moves us one step closer in our efforts to bring OCU400, a novel gene-agnostic modifier gene therapy, to market as a potential life-changing treatment for children afflicted with inherited retinal diseases, such as RP and LCA,” noted Arun Upadhyay, PhD, Ocugen’s Chief Scientific Officer. “This approval further demonstrates the consistent, positive, and timely progress we are making with the Phase 1/2 trial in adult patients. Since a significant number of individuals in the pediatric age group are diagnosed with RP and LCA, it is very important for us to cover this age group in our clinical trials.”

Enrollment of adult RP patients in the Phase 1/2 trial is complete—per protocol—and enrollment continues among patients with LCA. The Company plans to initiate the Phase 3 trial near the end of 2023.

Unlike single-gene replacement therapies, which only target one genetic mutation, Ocugen believes that its modifier gene therapy platform, through its use of Nuclear Hormone Receptors (NHRs), represents a novel approach that has the potential to address multiple retinal diseases caused by mutations in multiple genes with one product, and potentially address complex diseases that are caused by imbalances in multiple gene-networks. While single-gene replacement therapies have shown tremendous promise in rare retinal diseases, they are highly specific and cannot improve a multitude of disease-causing genetic defects. For example, RP and LCA are associated with mutations in more than 100 and in more than 25 genes, respectively. Ocugen is the only company with a gene-agnostic modifier platform that aims to alter this single-gene therapy paradigm through the introduction of a functional gene to modify the expression of multiple genes and gene-networks. We believe that patient prevalence in the United States alone would provide significant long-term value, with RP and LCA affecting 110,000 and 15,000 people, respectively.

OCU400 is the Company’s gene-agnostic modifier gene therapy product based on NHR gene, NR2E3. NR2E3 regulates diverse physiological functions within the retina—such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation and cell survival networks. Through its diverse functionality, OCU400 resets altered/affected cellular gene-networks and establishes homeostasis—a state of balance, which has the potential to improve retinal health and function in patients with inherited retinal diseases.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
IR@ocugen.com 

Release – Tonix Pharmaceuticals Announces Oral Presentations at the World Vaccine Congress

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

March 27, 2023 7:00am EDT

CHATHAM, N.J., March 27, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that Zeil Rosenberg, M.D., M.P.H., Executive Vice President, Medical and Farooq Nasar, Ph.D., Senior Principal Investigator, both of Tonix Pharmaceuticals, will deliver oral presentations at the World Vaccine Congress, which will be held in Washington D.C., April 3 – 6, 2023. Copies of the Company’s presentations will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the World Vaccine Congress website here.

In addition, Sina Bavari, Ph.D., Executive Vice President, Infectious Disease Research and Development of Tonix Pharmaceuticals will be moderating a panel of key opinion leaders discussing Mpox and the challenges and opportunities in vaccine development.

Oral Presentation Details

Presenter:Zeil Rosenberg, M.D., M.P.H. (Tonix Pharmaceuticals)
  
Title:A Live Attenuated Orthopoxvirus (Horsepox) Vaccine for Mpox and Smallpox
  
Location:Walter E. Washington Convention Center, Washington D.C.
  
Date:Wednesday April 5, 2023
  
Time:12:25 p.m. ET
  

Oral Presentation Details

Presenter:Farooq Nasar, Ph.D. (Tonix Pharmaceuticals)
  
Title:The Development of Horsepox Virus as a Vaccine Platform: Evaluation of TNX-1800 as a SARS-CoV-2 Vaccine
  
Location:Walter E. Washington Convention Center, Washington D.C.
  
Date:Thursday April 6, 2023
  
Time:10:10 a.m. ET
  

Panel Details

Title:Mpox – Challenges and Opportunities in Vaccine Development
  
Panel:Sina Bavari, Ph.D. (Tonix Pharmaceuticals); David Evans, Ph.D. (University of Alberta); Jose Esparza, M.D., Ph.D. (University of Maryland); Deborah Birx, M.D. (BGR Group); Michael Merchlinsky, Ph.D. (HHS/BARDA)
  
Location:Walter E. Washington Convention Center, Washington D.C.
  
Date:Thursday April 6, 2023
  
Time:11:30 a.m. ET
  

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition, for which a Phase 2 study was initiated in the third quarter of 2022. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is currently enrolling with interim data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation of tianeptine being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the second quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the second half of 2023. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900, a class of broad-spectrum small molecule oral antivirals.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505 

Source: Tonix Pharmaceuticals Holding Corp.

Released March 27, 2023

Release – Schwazze Announces Appointment to The Board of Directors

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SHWZ

March 24, 2023

OTCQX: SHWZ
NEO: SHWZ

DENVER, March 24, 2023 /CNW/ – Medicine Man Technologies Inc. operating as Schwazze, (OTCQX: SHWZ); (NEO: SHWZ) (“Schwazze” or the “Company”), today announced the appointment of Mr. Bradley Stewart to the Board of Directors of Schwazze. The Company also reports that Mr. Sal Wahdan has resigned as a Director of Schwazze.

Mr. Stewart is a Private Equity-backed CEO, board member and advisor, where he specializes in building technology and services companies with a focus on strategic transformation, balance sheet restructuring and M&A.  He currently, serves as Senior Advisor at Sixth Street, as Chairman at Perch and as an independent board member at Private Medical and Semper Paratus (Nasdaq: LGSTU).

Previously, Mr. Stewart was CEO at Fair Technologies, a fintech / marketplace backed by SoftBank Group. Prior to Fair, he was Chairman and CEO at XOJet, the largest on-demand private jet services company in North America, backed by TPG and Mubadala, where he led the company’s turnaround. In concurrence with XOJet, he was a Senior Advisor at TPG, a leading private equity firm, where he served on the board of directors for multiple TPG portfolio companies.  Prior to his tenure at XOJet and TPG, he was a Vice President at Parthenon Capital, a leading mid-market private equity firm, and formerly an Engagement Manager at McKinsey & Company.  He received an MBA from Columbia Business School, a BSB in Corporate Finance from the University of Minnesota’s Carlson School of Management and a Lower Division Completion Certificate from the University of Minnesota’s College of Science & Engineering.

Justin Dye, CEO of Schwazze stated, “We look forward to Brad’s participation on the Board of Directors of Schwazze as his strong experience and skills will be an excellent addition to our Board and the Company.  We also would like to thank Sal for his valuable contributions to the Board and wish him well in his future endeavours.” 

About Schwazze
Schwazze (OTCQX: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high- performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices. Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth.

Forward-Looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “plan,” “will,” “may,” “continue,” “predicts,” or similar words. Forward-looking statements include the guidance provided regarding the Company’s Q4 2022 performance and annual capital spending. Forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; (v) difficulties in securing regulatory approval to market our products and product candidates; (vi) our ability to successfully execute our growth strategy in Colorado and outside the state, (vii) our ability to identify and consummate future acquisitions that meet our criteria, (viii) our ability to successfully integrate acquired businesses and realize synergies therefrom, (ix) the ongoing COVID-19 pandemic, * the timing and extent of governmental stimulus programs, (xi) the uncertainty in the application of federal, state and local laws to our business, and any changes in such laws, and (xii) our ability to achieve the target metrics, including our annualized revenue and EBIDTA run rates set out in our Q4 2022 guidance. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.

View original content to download multimedia:https://www.prnewswire.com/news-releases/schwazze-announces-appointment-to-the-board-of-directors-301781179.html

SOURCE Schwazze

Motorsport Games (MSGM) – Pushes Out IndyCar Launch

Posted on by cpereira@noblefcm.com


Monday, March 27, 2023

Motorsport Games, a Motorsport Network company, combines innovative and engaging video games with exciting esports competitions and content for racing fans and gamers around the globe. The Company is the officially licensed video game developer and publisher for iconic motorsport racing series across PC, PlayStation, Xbox, Nintendo Switch and mobile, including NASCAR, INDYCAR, 24 Hours of Le Mans and the British Touring Car Championship (“BTCC”). Motorsport Games is an award-winning esports partner of choice for 24 Hours of Le Mans, Formula E, BTCC, the FIA World Rallycross Championship and the eNASCAR Heat Pro League, among others.

Michael Kupinski, Director of Research, Noble Capital Markets, Inc.

Patrick McCann, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Q4 results The company reported revenue of $3.8 million and an adj. EBITDA loss of $3.5 million in the quarter, roughly in line with our estimates. The quarter was driven by the successful release of NASCAR Rivals on the Nintendo Switch and reduced compensation expenses. The company made an investment in its user base by releasing a free DLC expansion pack for NASCAR 21: Ignition.

2023 outlook. The company announced the highly anticipated launch of its IndyCar game will be delayed until 2024. Management attributed the delay to an increased focus on quality, given that an Indy game has not been released in over a decade. As such, we are lowering our estimates in anticipation of adverse effects on revenue in 2023.


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Deep Fakes and the Risk of Abuse

Posted on by phoffman@channelchek.com
Image Credit: Steve Juvetson (Flickr)

Watermarking ChatGPT and Other Generative AIs Could Help Protect Against Fraud and Misinformation

Shortly after rumors leaked of former President Donald Trump’s impending indictment, images purporting to show his arrest appeared online. These images looked like news photos, but they were fake. They were created by a generative artificial intelligence system.

Generative AI, in the form of image generators like DALL-E, Midjourney and Stable Diffusion, and text generators like Bard, ChatGPT, Chinchilla and LLaMA, has exploded in the public sphere. By combining clever machine-learning algorithms with billions of pieces of human-generated content, these systems can do anything from create an eerily realistic image from a caption, synthesize a speech in President Joe Biden’s voice, replace one person’s likeness with another in a video, or write a coherent 800-word op-ed from a title prompt.

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of, Hany Farid, Professor of Computer Science, University of California, Berkeley.

Even in these early days, generative AI is capable of creating highly realistic content. My colleague Sophie Nightingale and I found that the average person is unable to reliably distinguish an image of a real person from an AI-generated person. Although audio and video have not yet fully passed through the uncanny valley – images or models of people that are unsettling because they are close to but not quite realistic – they are likely to soon. When this happens, and it is all but guaranteed to, it will become increasingly easier to distort reality.

In this new world, it will be a snap to generate a video of a CEO saying her company’s profits are down 20%, which could lead to billions in market-share loss, or to generate a video of a world leader threatening military action, which could trigger a geopolitical crisis, or to insert the likeness of anyone into a sexually explicit video.

Advances in generative AI will soon mean that fake but visually convincing content will proliferate online, leading to an even messier information ecosystem. A secondary consequence is that detractors will be able to easily dismiss as fake actual video evidence of everything from police violence and human rights violations to a world leader burning top-secret documents.

As society stares down the barrel of what is almost certainly just the beginning of these advances in generative AI, there are reasonable and technologically feasible interventions that can be used to help mitigate these abuses. As a computer scientist who specializes in image forensics, I believe that a key method is watermarking.

Watermarks

There is a long history of marking documents and other items to prove their authenticity, indicate ownership and counter counterfeiting. Today, Getty Images, a massive image archive, adds a visible watermark to all digital images in their catalog. This allows customers to freely browse images while protecting Getty’s assets.

Imperceptible digital watermarks are also used for digital rights management. A watermark can be added to a digital image by, for example, tweaking every 10th image pixel so that its color (typically a number in the range 0 to 255) is even-valued. Because this pixel tweaking is so minor, the watermark is imperceptible. And, because this periodic pattern is unlikely to occur naturally, and can easily be verified, it can be used to verify an image’s provenance.

Even medium-resolution images contain millions of pixels, which means that additional information can be embedded into the watermark, including a unique identifier that encodes the generating software and a unique user ID. This same type of imperceptible watermark can be applied to audio and video.

The ideal watermark is one that is imperceptible and also resilient to simple manipulations like cropping, resizing, color adjustment and converting digital formats. Although the pixel color watermark example is not resilient because the color values can be changed, many watermarking strategies have been proposed that are robust – though not impervious – to attempts to remove them.

Watermarking and AI

These watermarks can be baked into the generative AI systems by watermarking all the training data, after which the generated content will contain the same watermark. This baked-in watermark is attractive because it means that generative AI tools can be open-sourced – as the image generator Stable Diffusion is – without concerns that a watermarking process could be removed from the image generator’s software. Stable Diffusion has a watermarking function, but because it’s open source, anyone can simply remove that part of the code.

OpenAI is experimenting with a system to watermark ChatGPT’s creations. Characters in a paragraph cannot, of course, be tweaked like a pixel value, so text watermarking takes on a different form.

Text-based generative AI is based on producing the next most-reasonable word in a sentence. For example, starting with the sentence fragment “an AI system can…,” ChatGPT will predict that the next word should be “learn,” “predict” or “understand.” Associated with each of these words is a probability corresponding to the likelihood of each word appearing next in the sentence. ChatGPT learned these probabilities from the large body of text it was trained on.

Generated text can be watermarked by secretly tagging a subset of words and then biasing the selection of a word to be a synonymous tagged word. For example, the tagged word “comprehend” can be used instead of “understand.” By periodically biasing word selection in this way, a body of text is watermarked based on a particular distribution of tagged words. This approach won’t work for short tweets but is generally effective with text of 800 or more words depending on the specific watermark details.

Generative AI systems can, and I believe should, watermark all their content, allowing for easier downstream identification and, if necessary, intervention. If the industry won’t do this voluntarily, lawmakers could pass regulation to enforce this rule. Unscrupulous people will, of course, not comply with these standards. But, if the major online gatekeepers – Apple and Google app stores, Amazon, Google, Microsoft cloud services and GitHub – enforce these rules by banning noncompliant software, the harm will be significantly reduced.

Signing Authentic Content

Tackling the problem from the other end, a similar approach could be adopted to authenticate original audiovisual recordings at the point of capture. A specialized camera app could cryptographically sign the recorded content as it’s recorded. There is no way to tamper with this signature without leaving evidence of the attempt. The signature is then stored on a centralized list of trusted signatures.

Although not applicable to text, audiovisual content can then be verified as human-generated. The Coalition for Content Provenance and Authentication (C2PA), a collaborative effort to create a standard for authenticating media, recently released an open specification to support this approach. With major institutions including Adobe, Microsoft, Intel, BBC and many others joining this effort, the C2PA is well positioned to produce effective and widely deployed authentication technology.

The combined signing and watermarking of human-generated and AI-generated content will not prevent all forms of abuse, but it will provide some measure of protection. Any safeguards will have to be continually adapted and refined as adversaries find novel ways to weaponize the latest technologies.

In the same way that society has been fighting a decadeslong battle against other cyber threats like spam, malware and phishing, we should prepare ourselves for an equally protracted battle to defend against various forms of abuse perpetrated using generative AI.